PRODUCTION DEVELOPMENT AND MEDICAL DEVICES

PROCESSING FOR THIRD PARTIES OF MEDICAL DEVICES

Signorini Medicale deals with the development and production of medical devices in spray cans, bottle, vial or syringe. The experience of 30 years in the aerosol can respond in a professional and timely manner to the demand for new products in the medical sector.

A family business founded in 1986, we work in the medical field providing all the experience acquired with regard to mixtures, dispersions, emulsions, etc. At the production site there are three cleanrooms that are both ISO 8 and ISO 7 classified.

RESEARCH AND DEVELOPMENT

The company specialises in product development from client ideas and specifications. A laboratory equipped for the development of Class I, IIa, IIb, and III Medical Devices both sterile and non-sterile is available. Internally all tests for aging are performed and all the required checks on the finished product as well as the random process controls necessary by operators are carried out in the quality control department. In addition, support is provided in the certification regulatory process for any new medical devices.

CERTIFICATIONS

The company avails itself on the ISS (public body of the Italian National Health Service) for marking its medical devices. Since April 2014, our quality management system is certified according to UNI CEI EN ISO 13485 and the certification was issued by the authorised body “Certiquality”.